UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044716 |
|---|---|
| Receipt number | R000051071 |
| Scientific Title | A study to evaluate the effect of dentist intervention on prognosis in patients with aspiration pneumonia. |
| Date of disclosure of the study information | 2021/06/30 |
| Last modified on | 2024/04/05 11:30:07 |
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Basic information
Public title
A study to evaluate the effect of dentist intervention on prognosis in patients with aspiration pneumonia.
Acronym
Study on the prognosis of aspiration pneumonia
Scientific Title
A study to evaluate the effect of dentist intervention on prognosis in patients with aspiration pneumonia.
Scientific Title:Acronym
Study on the prognosis of aspiration pneumonia
Region
| Japan |
Condition
Condition
aspiration pneumonia
Classification by specialty
| Medicine in general | Geriatrics | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the prognosis of aspiration pneumonia with dentist intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of recurrence rate of aspiration pneumonia by dentist intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention Group: Oral care by a dentist. Once a week for a total of one month
Control Group: Oral care by nurses
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were admitted to Juntendo Koto Geriatric Medical Center and met the diagnostic criteria for aspiration pneumonia.
The criteria for aspiration pneumonia were fulfilled both 1)-3).
1) Radiological findings compatible with aspiration pneumonia on chest x-ray or CT.
2) Witnessing of aspiration by family members, caregivers, medical staff, or others, or factors suggestive of aspiration.
3) Acute respiratory symptoms suggestive of pneumonia (cough, sputum, fever, dyspnea).
Key exclusion criteria
Exclusion criteria
(1) Patients admitted with aspiration pneumonia who do not meet the above diagnostic criteria
(2) Patients diagnosed with cancer, tuberculosis, or viral pneumonia
(3) Patients who were readmitted to the hospital, the data from the first hospitalization will be used to avoid duplication.
(4) Other patients who are judged by the principal investigator to be inappropriate as research subjects.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Miyagami |
| Middle name | |
| Last name | Taiju |
Organization
Juntendo University
Division name
General medicine department
Zip code
113-8431
Address
Tokyo-to Bunkyo-ku Hongo 3-1-3
TEL
0338133111
tmiyaga@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Miyagami |
| Middle name | |
| Last name | Taiju |
Organization
Juntendo University
Division name
General medicine department
Zip code
113-8431
Address
Tokyo-to Bunkyo-ku Hongo 3-1-3
TEL
0338133111
Homepage URL
tmiyaga@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University
Address
Tokyo-to Koto-ku Shinsuna 3-3-20
Tel
0356323111
kubota_kei@juntendo.gmc.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
185
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 30 | Day |
Last modified on
| 2024 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051071
